Apparatus and methods for positioning a vascular sheath

ABSTRACT

An apparatus for positioning an introducer sheath includes a sheath having a distal end including first and second ports, the second port being located distally from the first port. An obturator is slidable within the sheath that includes a distal region that sealingly engages an interior surface of the sheath. The obturator includes first and second openings in the distal region that are alignable with the first and second ports in the sheath. A housing is slidable on the exterior of the sheath that releasably holds a closure element. The sheath may be inserted into an incision communicating with a blood vessel, the first and second ports providing backbleed indication of the depth of the insertion of the sheath into the vessel. The housing is actuated to deploy the closure element to engage and close the incision.

RELATED INFORMATION

This application is a continuation of application Ser. No. 09/680,837filed on Oct. 6, 2000 now U.S. Pat. No. 6,626,918. The priority of thisprior application is expressly claimed, and the disclosure of the priorapplication is hereby incorporated by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates generally to apparatus and methods forclosing and/or sealing openings into body lumens, and more particularlyto apparatus and methods for delivering a vascular closure element forclosing an iatrogenic puncture in a blood vessel formed during adiagnostic or therapeutic procedure.

BACKGROUND

Catheterization and interventional procedures, such as angioplasty orstenting, generally are performed by inserting a hollow needle through apatient's skin and muscle tissue into the vascular system. A guide wiremay then be passed through the needle lumen into the patient's bloodvessel accessed by the needle. The needle may be removed, and anintroducer sheath may be advanced over the guide wire into the vessel. Acatheter may then be advanced through a lumen of the introducer sheathand over the guide wire into a position for performing a medicalprocedure. Thus, the introducer sheath may facilitate introduction ofvarious devices into the vessel, while minimizing trauma to the vesselwall and/or minimizing blood loss during a procedure.

Upon completion of the procedure, the catheter and introducer sheath maybe removed, leaving a puncture site in the vessel wall. Externalpressure may be applied to the puncture site until clotting and woundsealing occur. This procedure, however, may be time consuming andexpensive, requiring as much as an hour of a physician's or nurse'stime. It is also uncomfortable for the patient, and requires that thepatient remain immobilized in the operating room, catheter lab, orholding area. In addition, a risk of hematoma exists from bleedingbefore hemostasis occurs.

Various apparatus have been suggested for percutaneously sealing avascular puncture by occluding the puncture site. For example, U.S. Pat.Nos. 5,192,302 and 5,222,974, issued to Kensey et al., describe the useof a biodegradable plug that may be delivered through an introducersheath into a puncture site. When deployed, the plug may seal the vesseland provide hemostasis. Such devices, however, may be difficult toposition properly with respect to the vessel, which may be particularlysignificant since it is generally undesirable to expose the plugmaterial, e.g., collagen, within the bloodstream, where it may floatdownstream and risk causing an embolism.

Another technique has been suggested that involves percutaneouslysuturing the puncture site, such as that disclosed in U.S. Pat. No.5,304,184, issued to Hathaway et al. Percutaneous suturing devices,however, may require significant skill by the user, and may bemechanically complex and expensive to manufacture.

To facilitate positioning devices that are percutaneously inserted intoa blood vessel, “backbleed” indicators have been suggested. For example,U.S. Pat. No. 4,317,445, issued to Robinson, discloses a flashbackchamber on a first end of a cannula that communicates with a port on asecond end. The second end is percutaneously introduced into a patientuntil the port enters the vessel, whereupon blood, under normal bloodpressure, may advance along the cannula and enter the flashback chamber,thereby providing a visual indication that the vessel has been entered.This reference, however, does not discuss vascular wound closure, but ismerely directed to an introducer device. In contrast, U.S. Pat. No.5,676,974, issued to Kensey et al., discloses a back bleed lumenintended to facilitate positioning of a biodegradable plug within apuncture site. This device, however, requires that an anchor of the plugbe positioned within the vessel, and therefore, may increase the risk ofover-advancement of the plug itself into the vessel.

Alternatively, U.S. Pat. No. 5,674,231, issued to Green et al.,discloses a deployable loop that may be advanced through a sheath into avessel. The loop is intended to resiliently expand to engage the innerwall of the vessel, thereby facilitating holding the sheath in a desiredlocation with respect to the vessel. The loop may also provide a supportfor facilitating the deployment and deflection of a surgical clipagainst the vessel wall. Such a device, however, may risk engagementbetween the loop and the surgical clip, thereby preventing the loop frombeing withdrawn from the vessel.

Accordingly, apparatus and methods for vascular puncture closure thatare simpler to manufacture and/or use, or that overcome thedisadvantages of known devices would be considered useful.

SUMMARY OF THE INVENTION

The present invention is directed to apparatus and methods for providingaccess into a blood vessel or other body lumen from an incision orpuncture, and/or for delivering a closure element for closing theincision.

In accordance with one aspect of the present invention, an apparatus isprovided that includes a sheath having proximal and distal ends, thedistal end having a size and shape for insertion into a body lumen. Thedistal end includes first and second ports therein, the second portbeing disposed at a more distal location than the first port. Anobturator is disposed within the sheath, the obturator including adistal region having a size for sealingly engaging an interior surfaceof the sheath. The obturator includes first and second openings in thedistal region, the first and second openings being alignable with thefirst and second ports in the sheath. First and second lumens extenddistally from the proximal end of at least one of the sheath and theobturator, the first and second lumens communicating with the first andsecond openings, respectively. One or more of the lumens may be locatedwithin the wall of one of the sheath or obturator, or may be defined bya region between the sheath and obturator.

In addition, the apparatus may include a closure element slidablydisposed on an exterior of the sheath, the closure element configuredfor engaging tissue adjacent an opening into a body lumen for closingthe opening. Preferably, a housing is slidably disposed on the exteriorof the sheath, the housing configured for releasably holding the closureelement. The housing may be actuable from a proximal end of the sheathfor advancing the closure element distally during deployment of theclosure element.

In a preferred embodiment, the first and second ports are axiallyaligned with one another. A marker may then be provided on the proximalend of the tubular sheath, the marker having a predetermined peripheralorientation about the sheath for identifying the peripheral location ofthe first and second ports.

During use, the obturator may be inserted into the sheath, and the firstand second ports may be aligned with the first and second openings whenthe obturator is fully inserted into the sheath. The obturator and thesheath may include cooperating detents for securing the obturatoraxially with respect to the sheath when the obturator is fully insertedinto the sheath. Alternatively, the first opening may be aligned withthe first port when the obturator is inserted a first distance into thesheath, and the second opening may be aligned with the second port whenthe obturator is inserted a second distance into the sheath.

In one embodiment, the first and second lumens may extend within theobturator between its proximal end and the first and second openings,respectively. Alternatively, the second lumen may extend axially throughthe obturator, and the first lumen may be defined by an annular lumenbetween the obturator and the sheath.

In accordance with another aspect of the present invention, an apparatusis provided for delivering a vascular closure element into engagementwith tissue adjacent an opening into a body lumen. The apparatusincludes a sheath having proximal and distal ends and an exteriorsurface. The sheath includes an interior surface defining a first lumenextending between the proximal and distal ends, and one or more ports inthe distal end communicating with the first lumen. A housing is slidablydisposed on the exterior of the sheath, the housing being configured forreleasably holding a closure element. The housing is actuable from aproximal end of the sheath for advancing the closure element distallyduring deployment of the closure element.

An obturator is insertable into the first lumen of the sheath, theobturator including a distal region configured for sealingly engagingthe interior surface of the sheath, thereby defining an annular regionbetween the obturator and the sheath proximal to the distal region. Theannular region may communicate with the one or more ports when theobturator is fully inserted into the sheath. A backbleed port may beprovided on the proximal end of the sheath, the backbleed portcommunicating with the first lumen.

In accordance with yet another aspect of the present invention, anapparatus is provided for introduction into an opening in a wall of abody lumen. The apparatus includes a sheath having proximal and distalends, the distal end having a size and shape for insertion into a bodylumen. The distal end of the sheath includes first and second portstherein, the second port being disposed at a more distal location thanthe first port. The sheath may include a clip housing, a peripheralmarker or other features, similar to the embodiments described above.

An obturator is disposed within the sheath, the obturator including adistal region having a size for sealingly engaging an inner surface ofthe sheath. The obturator is movable with respect to the sheath forselectively opening and closing the first and second side ports topermit fluid flow therethrough to the proximal end of the sheath. In oneembodiment, the obturator at least partially defines a first lumenextending from the proximal end of the sheath towards the distal regionof the obturator. The obturator preferably includes a region forselectively sealing the first and second ports in the sheath, wherebyonly one of the first and second ports communicates with the firstlumen.

Preferably, the first lumen is defined between the obturator and theinner surface of the sheath. The obturator may include a second lumentherein having an inlet proximal to the distal region of the obturatorand a piston for sealingly engaging the inner surface of the sheath. Thepiston may be located proximal to the inlet, whereby the second lumencommunicates with the second side port when the obturator is disposed ata first position, and the first lumen communicates with the first sideport when the obturator is disposed at a second position. The obturatormay movable axially or rotated with respect to the sheath between thefirst and second positions.

Other objects and features of the present invention will become apparentfrom consideration of the following description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a first preferred embodiment of a vascularsheath and obturator, including a clip delivery device, in accordancewith the present invention.

FIG. 2 is a cross-sectional view of the obturator and vascular sheath ofFIG. 1, with the obturator fully inserted into the vascular sheath.

FIG. 3 is a cross-sectional view of the vascular sheath of FIG. 1inserted through an incision into a blood vessel.

FIG. 4 is a cross-sectional view of the vascular sheath of FIG. 3 withthe obturator of FIG. 1 fully inserted therein, showing side ports inthe vascular sheath being disposed outside the blood vessel.

FIG. 5 is a cross-sectional view of the vascular sheath and obturator ofFIG. 4 with the sheath advanced such that the side ports are disposedinside the blood vessel.

FIG. 6 is a side view of a second preferred embodiment of a vascularsheath and obturator, in accordance with the present invention.

FIG. 7 is a cross-sectional view of the obturator and vascular sheath ofFIG. 6, with the obturator fully inserted into the vascular sheath.

FIG. 8 is a cross-sectional view of the vascular sheath and obturator ofFIG. 6 inserted through an incision into a blood vessel, showing sideports in the vascular sheath being disposed outside the blood vessel.

FIG. 9 is a cross-sectional view of the vascular sheath and obturator ofFIG. 6 with the sheath advanced such that the side ports are disposedinside the blood vessel.

FIG. 10 is a side view of a third preferred embodiment of a vascularsheath and obturator, in accordance with the present invention.

FIG. 11 is a cross-sectional view of the obturator and vascular sheathof FIG. 10, with the obturator fully inserted into the vascular sheath.

FIGS. 12 and 13 are cross-sectional views of the vascular sheath andobturator of FIG. 10 with the sheath advanced such that first and secondbackbleed ports in the vascular sheath are disposed within the bloodvessel, and only first backbleed ports in the vascular sheath aredisposed within the blood vessel, respectively.

FIGS. 14A and 14B are cross-sectional views of a blood vessel, showinganother preferred embodiment of a vascular sheath and obturator,including a pair of axially aligned backbleed ports in the vascularsheath.

FIGS. 15A and 15B are cross-sectional views of a vascular sheath andobturator, showing first and second side ports in the sheath beingselectively opened, respectively.

FIGS. 16A and 16B are cross-sectional views of an alternative embodimentof a vascular sheath and obturator, showing first and second side portsin the sheath being selectively opened, respectively.

FIGS. 17A and 17B are cross-sectional views of yet another alternativeembodiment of a vascular sheath and obturator, showing first and secondside ports in the sheath being selectively opened, respectively.

FIGS. 17C through 17H are cross-sectional views of the vascular sheathand obturator of FIGS. 17A and 17B.

FIG. 18 is a detail of a clip housing on an introducer sheath, inaccordance with the present invention.

FIGS. 19A–19C are, respectively, views of a bioabsorbable clip andfastener of the present invention shown in top view in a deliveryconfiguration, in side view in the delivery configuration, and in sideview in a deployed configuration.

FIGS. 20A and 20B are isometric views of an alternative embodiment ofthe bioabsorbable surgical clip and fastener, constructed in accordancewith the present invention and shown, respectively, in a deliveryconfiguration and in a deployed configuration.

FIGS. 21A–21B through 24A–24B are side-sectional views of the closurecomponent in use at a vascular puncture site.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now to the drawings, FIGS. 1–5 show a first preferred embodimentof an apparatus 10 for providing access into a blood vessel 90 or otherbody lumen from an incision or puncture 92 and/or for delivering aclosure element (not shown) for closing the incision 92. Generally, theapparatus 10 includes a vascular sheath 12 and an obturator 14. Thesheath 12 is a substantially flexible or semi-rigid tubular bodyincluding a lumen 16 extending between its proximal and distal ends 18,20. The distal end 20 has a size and shape to facilitate insertion intoa blood vessel, e.g., having a tapered tip 22 for facilitatingsubstantially atraumatic introduction through the incision 92 andpartial insertion into the vessel 90. The lumen 16 has a size toaccommodate insertion of endoluminal devices therethrough, such as acatheter, guidewire, and the like (not shown).

A housing 24 is slidably disposed on an exterior of the sheath 12, thehousing 24 configured for releasably holding a closure element (notshown). In a preferred embodiment, the closure element is anannular-shaped clip (not shown), including one or more barbs forengaging the tissue around the incision 92 adjacent to the wall 98 ofthe vessel 90. Preferably, the clip is configured for drawing the tissuearound the incision 92 at the wall 98 of the vessel 90 substantiallyclosed and/or for enhancing hemostasis within the incision 92.

The housing 24 is actuable from the proximal end 18 of the sheath 12,for example, by handle 26, for advancing the closure element distallyduring deployment, as described further below. Exemplary embodiments ofa housing and closure element for use with an apparatus in accordancewith the present invention are disclosed in co-pending application Ser.No. 09/478,179, filed Jan. 5, 2000, Ser. No. 09/546,998, filed Apr. 11,2000, and Ser. No. 09/610,238, filed Jul. 5, 2000, the disclosures ofwhich are expressly incorporated herein by reference.

The obturator 14 is a substantially flexible, or semi-rigid elongatebody 28 having a proximal end 30 and an enlarged distal end 32. A handle34 is provided on the proximal end 28 that includes an annular ridge 36or other detent thereon that may engage a complementary-shaped pocket 38or other cooperating detent in the sheath 12 for substantially securingthe obturator 14 when it is disposed within the sheath 12, as describedfurther below. The sheath 12 also preferably includes a seal (notshown), such as a hemostatic valve, within the lumen 16 at or near theproximal end 18 that provides a fluid-tight seal, yet accommodatesinsertion of devices, such as the obturator 14, into the lumen 16without fluid passing proximally from the sheath 12.

The distal end 32 of the obturator 14 has a configuration for slidably,but sealably engaging an inner wall 40 of the sheath 12. The distal end32 of the obturator 14 may also be substantially soft and/or flexible,possibly including a pigtail (not shown), to facilitate atraumaticadvancement into a blood vessel. Alternatively, the distal end 32 of theobturator 14 may be expandable from a contracted configuration forfacilitating insertion into the sheath 12 to an enlarged configurationfor sealingly engaging the inner wall 40 of the sheath 12. For example,the distal end of the obturator 14 may be an inflatable balloon (notshown), and the obturator 14 may include an inflation lumen (also notshown) communicating from the proximal end 30 to an interior of theballoon for introducing fluid, such as saline, into the balloon toexpand it into engagement with the inner wall 40 of the sheath 12.

The sheath 12 includes one or more, and preferably a plurality of,distal side ports 42 at or near the distal end 20 that communicate withthe lumen 16. The distal side ports 42 may be disposed circumferentiallyabout a predetermined location with respect to the housing 24, asdescribed further below. The sheath 12 also preferably includes aproximal side port 44 at or near the proximal end 18 that alsocommunicates with the lumen 16, and also communicates with flush port46, or other valve or backbleed indicator (not shown). As best seen inFIG. 2, when the obturator 14 is fully inserted into the lumen 16, thecooperating ridge and pocket 36, 38 engage one another to preventinadvertent axial movement of the obturator 14 with respect to thesheath 12. In addition, the obturator 14 and sheath 12 together definean annular region 48 that communicates with both the distal and proximalside ports 42, 44 in the sheath 12.

As best seen in FIG. 3, the sheath 12 may be inserted or otherwisepositioned within a blood vessel 90, i.e., through an incision,puncture, or other opening 92 that extends from a patient's skin 94through any intervening tissue 96, and a wall 98 of the vessel 90. Thesheath 12 may be advanced over a guidewire or other rail (not shown)previously positioned through the incision 92 into the blood vessel 90using a conventional procedure. Preferably, the blood vessel 90 is aperipheral vessel, such as a femoral or carotid artery, although otherbody lumens may be accessed using the sheath 12, as will be appreciatedby those skilled in the art.

The incision 92, and consequently the sheath 12, are preferably orientedat a substantially acute angle “A” with respect to the vessel 90,thereby facilitating introduction of devices through the lumen 16 of thesheath 12 into the vessel 90 with minimal risk of damage to the vessel90. One or more devices, such as a guide wire, a catheter, and the likemay be inserted through the sheath 12 and advanced to a desired locationwithin the patient's body. For example, the devices may be used toperform a therapeutic or diagnostic procedure, such as angioplasty,atherectomy, stent implantation, and the like, within the patient'svasculature.

After the procedure is complete, the device(s) may be removed from thesheath 12, and the obturator 14 inserted through the hemostatic valve(not shown) into the lumen 16, e.g., until the distal end 32 extendsbeyond the distal end 20 of the sheath 12 and/or the cooperating detents36, 38 are engaged, as shown in FIG. 4. Preferably, when the obturator14 is fully inserted into the sheath 12, the distal side ports 42communicate with the annular region 48. The sheath 12 and obturator 14may then be moved in conjunction with one another, and preferably aretogether partially withdrawn from the vessel 90, as shown in FIG. 4.Preferably, the sheath 12 is positioned such that the distal side ports42 are adjacent to and not within the vessel 90. Fluid, such as saline,may be directed into the flush port 46 to flush blood or other visiblebody fluid from the proximal side port 44.

As shown in FIG. 5, the sheath 12 and obturator 14 may then be advanceduntil the distal side ports 42 enter the blood vessel 90. Internal bloodpressure within the blood vessel 90, which is substantially greater thanthe pressure encountered at the flush port 46, causes blood to enter thedistal side ports 42, pass through the annular region 48, and exit theproximal side port 44. The flush port 46 may include substantiallytransparent tubing 47 such that the blood may be seen or a transparentcannula, chamber or other device may be connected to the flush port 46.Thus, the blood provides a visual indication that the sheath 12 andobturator 14 are properly positioned with respect to the wall 98 of theblood vessel 90.

With the sheath 12 properly positioned, the housing 24 may then beactuated, for example, to advance the housing 24 distally into theincision 92 to deliver the closure element (not shown). Preferably, thehousing 24 may only be advanced a predetermined distance such that theclosure device substantially engages the wall 98 of the blood vesselaround the incision 92, e.g., until the barbs thereon penetrate but donot pass completely through the wall 98. Thus, the distal side ports 42may be provided a predetermined distance from the distal end 18 of thesheath 12 and the housing 24 may be advanced only a predetermineddistance, thereby providing a predetermined distance therebetween thatmay facilitate proper deployment of the closure element with respect tothe wall 98 of the vessel 90.

Turning to FIGS. 6–9, another preferred embodiment of an apparatus 110is shown that includes a sheath 12 that is substantially identical tothe previous embodiment, and an obturator 114. The obturator 114 is asubstantially flexible, or semi-rigid elongate body 128 slidablyengageable within a lumen 16 of the sheath 12 and having a proximal end130 and a distal end 132. An annular ridge 136 is provided on theproximal end 130 that may engage a complementary-shaped pocket 38 orother cooperating detent in the sheath 12 for substantially securing theobturator 114 when it is fully inserted into the sheath 12. The distalend 132 of the obturator 114 may include a substantially flexiblepigtail 133 that may facilitate atraumatic advancement into a bloodvessel. As best seen in FIG. 7, the obturator 132 also includes a lumen148 that extends from a proximal outlet 147 to an annular distal recess149.

Turning to FIG. 8, the sheath 12 may be positioned within a blood vessel90 through an incision 92 such that the distal side ports 42 do notcommunicate with an interior of the vessel 90. After one or more devices(not shown) are inserted through the sheath 12 to perform a desiredprocedure, the obturator 114 may be inserted into the lumen 16 until thedistal end 132 extends beyond the distal end 20 of the sheath 12 and/orthe cooperating detents 136, 38 are engaged. Preferably, when theobturator 114 is fully received within the sheath 12, the distal sideports 42 communicate with the annular recess 149. The sheath 12 andobturator 114 may then be moved in conjunction with one another, andpreferably are together positioned such that the distal side ports 42are adjacent to and not within the vessel 90.

As shown in FIG. 9, the sheath 12 and obturator 114 may then be advanceduntil the distal side ports 42 enter the blood vessel 90. Internal bloodpressure within the blood vessel 90 causes blood to enter the distalside ports 42 into the annular recess 149, pass through the lumen 148,and exit the proximal outlet 147. Thus, blood exiting the proximaloutlet may provide a visual indication that the sheath 12 and obturator114 are properly positioned with respect to the wall 98 of the bloodvessel 90. The housing 24 may then be actuated to deliver the closureelement, as described above.

Turning to FIGS. 10–13, yet another preferred embodiment of an apparatus210 is shown that includes a sheath 212, and an obturator 214 insertableinto the sheath 212. The sheath 212 includes a lumen 216 extendingbetween its proximal and distal ends 218, 220. A housing 224 may beslidably disposed on an exterior of the sheath 212, the housing 224configured for releasably holding a closure element, as described above(not shown).

The sheath 212 includes first and second sets of side ports 242, 250,each set preferably including a plurality of side ports that communicatewith the lumen 216. The distal side ports 242 may be disposedcircumferentially about a predetermined location along a length of thesheath 212, e.g., at a predetermined axial location with respect to thehousing 224. The sheath 12 may also include a proximal side port 244 ator near the proximal end 218 that also communicates with the lumen 216,to which flush port 246 is connected. The sheath 212 also may include aseal (not shown) within the lumen 216 at or near the proximal end 218that provides a fluid-tight seal, yet accommodates insertion of theobturator 214 into the lumen 216 without fluid passing proximally fromthe sheath 212.

The obturator 214 is a substantially flexible, or semi-rigid elongatebody 228 having a size for slidably, but sealingly engaging an innerwall 240 of the sheath 212, and including a proximal end 230 and adistal end 232. An annular ridge 236 is provided on the proximal end 230that may engage a complementary-shaped pocket 238 in the sheath 212 forsubstantially securing the obturator 214 within the sheath 212, similarto the embodiments described above. The distal end 232 of the obturator214 my also be substantially soft and/or flexible, possibly including apigtail (not shown), to facilitate atraumatic advancement into a bloodvessel.

The obturator 214 includes first and second lumens 248, 252 that includefirst and second sets of distal openings 249, 253 and proximal openings247, 251. Preferably, when the obturator 214 is fully received in thesheath 212, e.g., when the cooperating detents 236, 238 engage oneanother, the first and second sets of distal openings 249, 253 areaxially aligned with the first and second sets of side ports 242, 250,respectively. The obturator 214 may be rotatable within the sheath 212to further line the openings 249, 253 and side ports 242, 250 such thatthe first and second sets of side ports 242, 250 may communicate withthe lumens 248, 252, respectively.

As best seen in FIGS. 12 and 13, during use of the apparatus 210, thesheath 212 may be disposed within a blood vessel 90 through an incision92. After a procedure is completed using instruments introduced throughthe sheath 212, the obturator 214 may be inserted into the lumen 216until the cooperating detents 236, 238 are engaged. If necessary, theobturator 214 may be rotated to align the first and second sets of sideports 242, 250 with the first and second sets of openings 249, 253,respectively. Alternatively, mating notches (not shown) may be provided,for example, on the cooperating detents 236, 238, that ensure that theobturator 214 and sheath 212 are rotatably aligned with one another.

The sheath 212 and obturator 214 may then be moved axially together intoor out of the vessel 90. As shown in FIG. 12, in one position, both setsof side ports 242, 250 are exposed within the vessel 90, and the bloodpressure therein, whereupon both proximal outlets 247, 251 may provide a“backbleed” visual indication. Alternatively, as shown in FIG. 13, onlythe distal or first set of side ports 242 may be exposed within thevessel 90, and provide a visual indication that the sheath 212 is notinserted as far as into the vessel 90 as in FIG. 12. In a furtheralternative, neither set of side ports 242, 250 may be provide a visualindication, indicating that the sheath 212 is withdrawn further orperhaps completely from the vessel 90.

Thus, a plurality of side ports at different axial positions along thesheath 212 may be used as a depth gauge, providing the user a visualindication that the sheath 212 is at one of a plurality of knownlocations or depths with respect to the vessel 90.

With the sheath 212 inserted a desired depth, the housing 224 may thenbe actuated to deliver the closure element (not shown). Alternatively,the housing and closure element may be eliminated, and the sheath 212and obturator 214 may be used as an introducer device having a depthgauge indicator, as will be appreciated by those skilled in the art.

Turning to FIGS. 14A and 14B, still another preferred embodiment of anapparatus 310 is shown that includes a sheath 312 and obturator 314similar to the previous embodiment. Unlike the previous embodiment,however, the sheath 312 includes first side port 342 and a second sideport 350 instead of a plurality of side ports in each set. The first andsecond side ports 342, 350 are axially aligned with one another, i.e.,at a similar peripheral location about the exterior of the sheath 312.The obturator 314 includes first and second annular recesses 349, 351that are spaced apart axially a distance similar to the distance betweenthe first and second side ports 342, 350. Thus, when the obturator 314is fully inserted into the sheath 312, the first and second side ports342, 350 are substantially aligned with the first and second annularrecesses 349, 351, respectively, such that the first and second sideports 342, 250 communicate with first and second lumens 348, 352 withinthe obturator 314. In an alternative embodiment, the obturator mayinclude a first lumen that may communicate with the first side port, andthe obturator may include a reduced diameter region, similar to theembodiment shown in FIGS. 1 and 2, such that the second side port maycommunicate with the annular region defined between the sheath and theobturator.

The apparatus 310 preferably includes a visible marker (not shown), forexample, on the proximal end (not shown) of the sheath 312 at apredetermined peripheral location. For example, the marker may beaxially aligned with the first and second side ports 342, 350 to therebyprovide a visual indication of the peripheral location of the side ports342, 350. The apparatus 310 may then be used similar to the embodimentsdescribed above to position the sheath 312 within a blood vessel 90and/or to deliver a closure element to close an incision 92communicating with the vessel 90. During this procedure, the marker maybe used to orient the sheath 312, for example, to rotate the side ports342, 350 into an “anterior” orientation, i.e., towards the outer surfaceof the patient's skin 94. This may provide more precise control of thedepth of the sheath, e.g., by taking into account the fact that thesheath 312 is inserted at an angle into the blood vessel 90, as will beappreciated by those skilled in the art.

Turning to FIGS. 15A and 15B, yet another embodiment of an apparatus 410is shown that includes a sheath 412, and an obturator 414, similar tothe previous embodiments. The apparatus 410 optionally may include aclip housing, clip, actuator handle and the like (not shown), e.g., onthe sheath 412, similar to the previous embodiments. The sheath 412includes first side port 442 and a second side port 450. The first andsecond side ports 442, 450 may be axially aligned with one another,i.e., at a similar peripheral location about the exterior of the sheath412, or they may be offset from one another about the periphery. Theobturator 414 includes an enlarged distal region 432, and a relativelynarrow region 428 extending between the distal region 432 and a proximalend 430 of the obturator 414.

A protrusion 429, which may be a partial annulus or a hub, extendsradially outward from the narrow region 428 to slidably engage an innerwall 440 of the sheath 412. The protrusion 429 is located apredetermined distance from the distal region 428 such that theprotrusion 429 may selectively open or close the first and seconds sideports 442, 450. When the obturator 414 is inserted a first distance intothe sheath 412, as shown in FIG. 15A, the protrusion 429 may sealablyobstruct the second side port 450, thereby allowing fluid to enter thefirst side port 442 and pass through an annular lumen 448 to a proximalside port 444. The obturator 414 and sheath 412 may include cooperatingdetents, e.g., annular ridge 436 and a first annular groove 438 a, forreleasably securing the obturator 414 in the first position shown inFIG. 15A.

As shown in FIG. 15B, the obturator 414 may be advanced distally to asecond position at which the protrusion 429 sealably obstructs the firstside port 442, thereby allowing fluid to enter the second side port 450.The sheath 412 may include a second annular groove 438 b for receivingthe ridge 436 on the obturator 414 for releasably securing the obturator414 in the second position.

During a procedure, the apparatus 410 may be used similar to theembodiments described above to position the sheath 412 within a bloodvessel and/or to deliver a closure element to close an incisioncommunicating with the vessel. First, the sheath 412 may be manipulated,e.g., advanced further into the vessel or retracted partially from thevessel, until the first and second side ports 442, 450 are positionedoutside the vessel, i.e., within the puncture passage. A marker (notshown) may be used to orient the sheath 412, for example, to rotate theside ports 442, 450 into an “anterior” orientation, as described above.The obturator 414 may be inserted into the sheath 412 until it reachesthe first position. The sheath 412 and obturator 414 may then bemanipulated together, i.e., advanced or retracted, until internal bloodpressure directs blood through the first side port 442 and into theproximal side port 444, indicating that the first side port 442 iswithin the vessel. The obturator 414 may then be advanced to the secondposition, occluding the first side port 442. The sheath 412 andobturator 414 may then be manipulated until blood enters the second sideport 450 and exits the proximal side port 444, indicating the precisedepth of the sheath 412.

Turning to FIGS. 16A and 16B, still another embodiment of an apparatus510 is shown that includes a sheath 512, including first side port 542and a second side port 550, and an obturator 514. The sheath 512optionally may include a clip housing, clip, actuator handle and thelike (not shown), similar to the previous embodiments. The first andsecond side ports 542, 550 may be axially aligned with one another,i.e., at a similar peripheral location about the exterior of the sheath512, or they may be offset from one another about the periphery. Theobturator 514 includes an enlarged distal region 532, and a relativelynarrow region 528 extending between the distal region 532 and a proximalend 530 of the obturator 514.

An annular piston 529 extends radially outward from the narrow region528 to slidably engage an inner wall 540 of the sheath 512, therebysealing a region distal of the piston 529, i.e., between the piston 529and the enlarged distal region 532. The piston 529 is located apredetermined distance from the distal region 528 such that the piston529 may selectively open or close the first and seconds side ports 542,550. The obturator 514 also includes a lumen 552 that extends from aproximal outlet 553 to a distal inlet 551 located distally of the piston529.

When the obturator 514 is inserted a first distance into the sheath 512,as shown in FIG. 16A, the piston 529 may sealably obstruct the secondside port 550, thereby allowing fluid to enter the first side port 542and pass through the obturator lumen 552 to the proximal outlet 553. Theobturator 514 and sheath 512 may include cooperating detents, e.g.,annular ridge 536 and a first annular groove 538 a, for releasablysecuring the obturator 514 in the first position shown in FIG. 16A.

As shown in FIG. 16B, the obturator 514 may be advanced distally to asecond position at which the piston 529 sealably obstructs the firstside port 550, thereby allowing fluid to enter the second side port 542and pass through the annular lumen 548 to proximal side port 544. Thesheath 512 may include a second annular groove 538 b for receiving theridge 536 on the obturator 514 for releasably securing the obturator 514in the second position.

The apparatus 510 may be used similar to the embodiments described aboveto position the sheath 512 within a blood vessel and/or to deliver aclosure element to close an incision communicating with the vessel. Amarker (not shown) may be used to orient the sheath 512, for example, torotate the side ports 542, 550 into an “anterior” orientation, asdescribed above. The obturator 514 may be inserted into the sheath 512until it reaches the first position. The sheath 512 and obturator 514may then be manipulated, i.e., advanced or retracted, until internalblood pressure directs blood through the first side port 542 and intothe proximal side port 544, indicating that the first side port 542 iswithin the vessel. The obturator 514 may then be advanced to the secondposition, occluding the first side port 550. The sheath 512 andobturator 514 may then be manipulated until blood enters the second sideport 542 and exits the proximal side port 544, indicating the precisedepth of the sheath 512.

Turning to FIGS. 17A–17H, yet another alternative embodiment is shown ofan apparatus 610, including a sheath 612, including first and secondside ports 642, 650, and an obturator 614. The sheath 612 optionally mayinclude a clip housing, clip, actuator handle and the like (not shown),similar to the previous embodiments. The first and second side ports642, 650 may be axially aligned with one another, i.e., at a similarperipheral location about the exterior of the sheath 612, as shown orthey may be offset from one another about the periphery (not shown). Theobturator 614 includes an enlarged distal region 632 that slidably andsealingly engages an inner wall 640 of the sheath 612. The obturator 614also includes a relatively narrow region 628 extending between thedistal region 632 and a proximal end 630 of the obturator 514, therebydefining an annular lumen 648 between the narrow region 628 and an innerwall 640 of the sheath 612.

A notch or slot 629 is provided in the distal region 632 of theobturator 614 that communicates with the lumen 648. The obturator 514also includes a lumen 652 that extends from a proximal outlet 653 to adistal inlet 651 located distally of the notch 629. Preferably, theoutlet 651 and the notch 629 are aligned with the first and second sideports 642, 650 when the obturator 614 is fully inserted into sheath 612.

The obturator 614 is rotatable within the sheath 612 between first andsecond positions. As best seen in FIGS. 17A and 17E, in the firstposition, the outlet 651 communicates with the first side port 642,while the second side port 650 is substantially sealed by the enlargeddistal portion 632 of the obturator 614. Thus, fluid may enter the firstside port 642 and pass through the obturator lumen 652 to the proximaloutlet 653. The obturator 614 and sheath 612 may include cooperatingdetents 636, 638 a for releasably securing the obturator 614 in thefirst position, as best seen in FIG. 17C.

As best seen in FIGS. 17B and 17G, the obturator 614 may be rotated tothe second position such that the enlarged distal region 632 of theobturator 614 sealably obstructs the first side port 650, while fluidmay freely enter the second side port 642 and pass through the notch 629into the annular lumen 648 to proximal side port 644. The sheath 612 mayinclude a second detent 638 b for engaging the detent 636 on theobturator 614 for releasably securing the obturator 614 in the secondposition.

The apparatus 510 may be used similar to the embodiments described aboveto position the sheath 512 within a blood vessel and/or to deliver aclosure element to close an incision communicating with the vessel,except that the obturator 614 is rotated within the sheath 612 ratherthan moved axially in order to selectively open or close the first andsecond side ports 642, 650. In an alternative embodiment, the obturator614 may include two lumens (not shown), one that may selectivelycommunicate with the respective first and second side ports 642, 650when the obturator 614 is rotated within the sheath 612, as will beappreciated by those skilled in the art.

Turning to FIG. 18, another embodiment of the present invention isshown, namely an apparatus 710 that includes a sheath or introducer 712,and a clip housing 714. The clip housing 714 includes an outer member716 defining an annular cavity 718, and an inner member 720 that ispartially receivable in the cavity 718. The inner member 720 includes atapered distal end 722 within which are one or more ports 724. The portscommunicate through a lumen 726 within the inner member 720 to a lumen728 within the outer member 718 and to tubes 730. The clip housing 714is slidable along an outer surface 732 of the sheath 712, and may beactuable, for example, using handle rods 734.

With the outer and inner members 716, 720 separated from one another, aclip or other closure device (not shown) may be placed within the cavity718. For example, the inner member 720 may be removed distally from thesheath 712, and a clip may be advanced over the distal end (not shown)of the sheath 712 and into the cavity 718. The inner member 720 may thenbe advanced over the distal end of the sheath 712 until it partiallyenters the cavity 716, i.e., substantially engages the outer member 716.For example, the inner and outer members 720, 716 may include acooperating groove 736 and notch (not shown) that may facilitatealignment and/or engagement of the inner and outer members 720, 716.

The sheath 712, with the clip housing 714 adjacent a proximal endthereof (not shown) may be placed through a puncture into a bloodvessel, for example, until the distal end of the sheath 712 is disposedwithin the vessel lumen (not shown). A procedure may be completed, e.g.,by introducing one or more instruments or other devices through thesheath 712 into the vessel. Upon completion of the procedure, the cliphousing 714 may be advanced towards the distal end of the sheath 712,i.e., through the puncture until the clip housing just enters thevessel. The tapered end 722 of the inner member 720 may facilitatesubstantially atraumatic advancement of the clip housing 714 through thepuncture with minimal harm to the surrounding tissue.

As the tapered end 722 enters the vessel, the ports 724 may communicatewith the lumen, thereby causing blood to enter the ports, travel throughthe lumens 726, 728 and the tubes 730, thereby providing an indicatorthat the clip housing 714 has been properly positioned within thepuncture. The clip housing 714 may then be activated, e.g., by rotatingthe rods 734 within slots 738, to deploy the clip. The sheath 712 maythen be withdrawn from the vessel and puncture site, leaving the clip inthe puncture site to substantially close the puncture opening into thevessel.

With reference now to FIGS. 19A–19C, bioabsorbable clip 846 and fastener860 are described in greater detail. FIG. 19A shows clip 846 in thedelivery configuration. Clip 846 comprises curved legs 870 and proximalend 872. Legs 870 distally terminate as spikes 874 with optionalengagement means 876, and proximally terminate at narrowed region 878.Engagement means 876 may comprise, for example, barbs or hooks.

Fastener 860 comprises bioabsorbable locking collar 880, which isslidably received on the exterior of clip 846. As seen in FIG. 19B,locking collar 880 may be distally advanced down the exterior of clip846 to deform the clip to its deployed configuration, wherein curvedlegs 870 and spikes 874 are drawn together. Clip 846 may then beseparated from clip holder 856 by rotating proximal end 872 with respectto legs 870, causing the clip to snap into two pieces at narrowed region878, for the reasons described hereinafter. Clip 846 and locking collar880 preferably are fabricated from bioabsorbable materials, such aspolyglycolic acid.

Referring to FIG. 20, an alternative embodiment of the closure componentof the present invention is described. Closure component 890 comprisesbioabsorbable clip 892 and fastener 894. Clip 892 comprises proximalhoop 896 with narrowed regions 898, and legs 900 terminating in spikes902. Fastener 894 comprises bioabsorbable wedge 904. Wedge 904 has adiameter substantially equal to the diameter of hoop 896 at its distalend, the diameter tapering to a maximum diameter at the proximal end ofwedge 904. Clip 892 therefore may be deformed from the deliveryconfiguration of FIG. 20A to the deployed configuration of FIG. 20B,wherein legs 900 and spikes 902 are drawn together, by advancing wedge904 into hoop 896 to deform clip 892 at narrowed regions 898. Lumen 906extends through hoop 898 of clip 892, while lumen 908 extends throughwedge 896. Clip 892 and wedge 896 therefore are configured for deliveryover the exterior of an introducer sheath. The clip and wedge preferablyare fabricated from bioabsorbable materials.

With reference to FIGS. 21A–21B through 24A–24B, in conjunction withFIGS. 1–3, methods of using vascular device 10 are described. Introducersheath 12 is advanced through skin, fat, and muscle tissue into vesselV, through vascular puncture P, which is formed in accordance withwell-known techniques. Vascular device 10 is used in the same manner asa standard introducer sheath. As shown in FIG. 21A, distal pins 850,mounted in housing 816, abut distal slots 866 and 868 of drivers 858 andholders 856, respectively.

FIG. 21B illustrates closure component 820 via sectional views. FIG. 21Ashows the locations of proximal pins 854 within proximal slots 862 and864, and the locations of distal pins 850 within distal slots 866 and868, corresponding to the relative longitudinal positions of clipholders 856 and locking collar drivers 858 depicted in FIG. 21B. Pinlocations are shown via side views of clip holders 856 and lockingcollar drivers 858 at the relevant locations.

As seen in FIGS. 21A and 21B, with clip housing 816 positioned atpuncture site P, proximal pins 854, mounted in caps 852. are positionedat the extreme right of proximal driver slots 862 and of thecircumferential portions of proximal holder slots 864. Distal pins 850are located at the distal end of distal driver slots 866 and of thelongitudinal portions of distal holder slots 868.

In FIGS. 22A and 22B, with clip housing 816 held immobile, force isapplied to caps 852 to distally advance clip 846 with respect to housing816. Specifically, proximal pins 854 abut and apply force againstproximal slots 862 and 864, which advances drivers 858 and clip holders856, as well as attached clips 846 and locking collars 880. Distal pins850 move freely within distal slots 866 and the longitudinal portions ofdistal slots 868. Distal advancement of clips 846 continues until pins850 abut against the proximal end of the longitudinal portions of distalholder slots 868 of clip holders 856. Drivers 858 likewise arerestrained by their connection to clip holders 856 via proximal pins854. The tissue-engaging members, spikes 874 and engagement means 876,of clips 846 contact and pierce the wall of vessel V on opposite sidesof the puncture site P.

-   -   As seen in FIGS. 23A and 23B, once the spikes have pierced the        vessel wall, locking collar drivers 858 are advanced distally        while clip housing 816 and clip holders 856 remain stationary,        thereby distally advancing locking collars 880 down the        exteriors of clips 846 to draw legs 870 and spikes 874 together        to close puncture P. Engagement means 876 serve to retain the        clips within the vessel wall during healing.

To achieve this advancement of drivers 858 with respect to clip holders856, caps 852 are rotated clockwise, as viewed from above, untilproximal pins 854 abut against the extreme left of proximal slots 862and 864, thereby aligning the pins with the longitudinal portions ofproximal holder slots 864. Then, force is once again applied to caps 852to advance drivers 858 and deform clips 846 to their deployedconfigurations. Specifically, proximal pins 854 abut and apply force toproximal driver slots 862, thereby distally advancing drivers 858. Pins854 move freely within the longitudinal portions of proximal holderslots 864 until they abut against the distal ends of slots 864.Likewise, distal driver slots 866 move freely until distal pins 850 abutthe proximal ends of slots 866. In FIG. 23A, when proximal pins 854 abutslots 864 and distal pins 850 abut slots 866, locking collars 880 havebeen driven down the exteriors of clips 846, thereby deforming the clipsto draw legs 870 together and close the puncture site.

In FIGS. 24A and 24B, with clips 846 deformed to seal puncture P, clipholders 856 are detached from clips 846 by snapping the clips free atnarrowed regions 878. At this point, or prior to detachment, a suitablebiocompatible bioglue or tissue sealant optionally may be injected intothe puncture tract, as discussed hereinabove, through device port 832 orside port 822, to aid in sealing vascular puncture P. Alternatively, thebioglue or tissue sealant may be delivered through the backbleed pathdescribed above. Vascular device 10 then is withdrawn from the vesselwall, completing the procedure.

Clips 846 are detached from clip holders 846 by rotating caps 852counterclockwise, as viewed from above. Proximal pins 854 of caps 852move freely within proximal driver slots 862, but abut against thedistal end of the longitudinal portions of proximal holder slots 864 andcause clip holders 856 to rotate with respect to collar drivers 858.Distal pins 850 of clip housing 816 move freely within thecircumferential portions of distal holder slots 868 during rotation ofclip holders 856. Meanwhile, drivers 858 are restrained from rotation bydistal pins 850, which abut against distal driver slots 866.Bioabsorbable clips 846 do not rotate because the square cross sectionof square clip bores 846 of drivers 858 matches the substantially squarecross section of clips 846, thus, since drivers 858 are restrained fromrotation, so are clips 846. Non-square cross sections for clips 846 andbores 847, capable of performing the restraining function, will beapparent to those of skill in the art and fall within the scope of thepresent invention.

Since clips 846 are restrained while clip holders 856 rotate, and sinceproximal ends 872 of clips 846 are attached to clip holders 856,counterclockwise rotation of caps 852 causes clips 846 to snap at theirweakest points: narrowed regions 878. Vascular device 10 may then beremoved from the patient to complete the procedure.

Although preferred illustrative embodiments of the present invention aredescribed above, it will be evident to one skilled in the art thatvarious changes and modifications may be made without departing from theinvention. For example, with minor modifications, vascular device 10 maybe configured to carry closure component 890 of FIG. 20, or any of avariety of alternative bioabsorbable and deformable clips. Proximal pins854 may be formed integrally with caps 852, and distal pins 850 may beformed integrally with clip housing 816. Any number of clips 846 may beused to close the vascular puncture.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the spiritand scope of the appended claims.

1. An apparatus for introduction into an opening in a wall of a bodylumen, comprising: a sheath having proximal and distal ends and aninterior surface defining a first lumen extending between the proximaland distal ends, the distal end having a size and shape for insertioninto a body and one or more ports communicating with the first lumen; anelongate member insertable into the first lumen of the sheath, theelongate member including a distal region configured for sealinglyengaging the interior surface of the sheath, the elongate member furtherincluding a shaft region extending proximally of the distal region andhaving an external surface that does not sealingly engage the interiorsurface of the sheath, thereby defining a first passage between theelongate member and the sheath proximal to the distal region, the firstpassage communicating with the one or more ports when the elongatemember is fully inserted into the sheath.
 2. The apparatus of claim 1,wherein the first passage comprises an annular region between theelongate member and the sheath proximal to the distal region of theelongate member.
 3. The apparatus of claim 2, wherein the elongatemember shaft comprises a generally cylindrical member having a diameterthat is less than a diameter of the first lumen of the sheath.
 4. Theapparatus of claim 1, wherein the elongate member distal region has acontracted state for insertion into the first lumen of the sheath and anelongated state for sealingly engaging the interior surface of thesheath.
 5. The apparatus of claim 1, wherein the sheath includes aproximal port in fluid communication with the first passage.
 6. Theapparatus of claim 1, wherein the elongate member includes a handle at aproximal end thereof, the handle adapted to engage the interior surfaceof the sheath.
 7. The apparatus of claim 6, wherein the elongate memberhandle includes a first engagement member and the interior surface ofthe sheath includes a second engagement member, and wherein said firstand second engagement members cooperate to substantially secure theelongate member relative to the sheath when the elongate member is fullyinserted into the sheath.
 8. The apparatus of claim 6, wherein theelongate member handle provides a seat between the elongate member andthe interior surface of the sheath.
 9. The apparatus of claim 1, furthercomprising a closure element slidably disposed on an exterior of thesheath, the closure element configured for engaging tissue adjacent theopening for closing the opening.
 10. The apparatus of claim 1, furthercomprising a housing slidably disposed on an exterior of the sheath, thehousing configured for releasably holding a closure element, the housingbeing actuable from a proximal end of the sheath for advancing theclosure element distally during deployment of the closure element.
 11. Amethod for positioning an introducer sheath in an opening in a wall ofbody passage through an incision in tissue, the introducer sheathincluding a lumen extending distally form its proximal end andcommunicating with at least one port in its distal end, the methodcomprising: inserting the distal end of the introducer sheath through apatient's skin toward the body passage via the opening; inserting anelongate member having a distal region into the introducer sheath lumenuntil a portion of a distal region extends distally of the distal end ofthe sheath, the distal region of the elongate member sealingly engagingan interior surface of the sheath, the elongate member and the interiorsurface of the sheath defining a first passage in fluid communicationwith the at least one port; positioning the distal end of the sheathwith respect to the body passage until the at least one port enters thebody passage, whereupon fluid within the body passage enters the firstpassage through the at least one port, thereby providing a visualindication of depth of insertion of the introducer sheath.
 12. Themethod of claim 11, further comprising viewing the fluid after it haspassed through a proximal port on said sheath, the proximal port influid communication with the first passage.
 13. The method of claim 11,further comprising distally advancing a closure element slidable on theintroducer sheath to engage tissue within or adjacent to the opening inthe wall of the body passage.
 14. The method of claim 13, furthercomprising distally advancing a housing slidable on the introducersheath, the housing configured for releasably holding a closure element,the housing being actuable from a proximal end of the introducer sheathfor advancing the closure element distally during deployment of theclosure element.